Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children

Safety Issues Clinical Trial

Official title:

Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680417
• Other study ID #: PMS-MR-0417
• Status: Completed
• Phase: Phase 4
• Start date: November 16, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2019
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants

Description:

• to asses serious immediate systemic events,

• to assess local and systemic reaction after Measles-Rubella (MR) vaccine in infants and children,

• to evaluate protectivity and antibody response to measles and rubella after 1 dose of MR vaccine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: August 1, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 47 Months

Eligibility

Inclusion Criteria:

• Healthy infants (9-12 months) or children (18-47 months)

• Will receive MR routine immunization.

• Parents have been informed properly regarding the study and signed the informed consent form.

• Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

• MR vaccine given simultaneously with other vaccination, except Pentabio (DTP/HB/Hib)

Related Conditions & MeSH terms

• Immunogenicity
• Measles
• Rubella
• Safety Issues

Intervention

Biological:
• Measles-Rubella (MR) Vaccine
Measles and Rubella Vaccine, live attenuated (Serum Institute of India) Form : Freeze dried Dose : 1 dose 0.5 ml contains not less than 1000 CCID50 of measles virus and 1000 CCID50 of rubella virus.

Locations

Country	Name	City	State
Indonesia	Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Immediate systemic events	Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination	30 minutes
Primary	Percentage of immediate systemic events	Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination	30 minutes
Secondary	Local reaction	Number of subjects with at least one local reaction occurring within 72 h after vaccination.	72 hours
Secondary	Systemic reaction	Number of subjects with at least one systemic event occurring within 72 h after vaccination.	72 hours
Secondary	Delayed Local reaction	Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.	11 days
Secondary	Delayed systemic event	Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.	11 days
Secondary	Late Local reaction	-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.	14 days
Secondary	Late Safety (Systemic event)	Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.	14 days
Secondary	Safety (serious adverse event)	- Number of serious adverse event occuring from inclusion until 28 days after immunization	28 days
Secondary	Immunogenicity for Measles (subject with anti measles titer = 8 (1/dil))	- Percentage of subjects with anti measles titer = 8 (1/dil), 28 days after one dose of MR vaccine in Infants & Children.	28 days
Secondary	Immunogenicity for Measles (Geometric Mean Titer)	- Geometric Mean Titer of measles antibody	28 days
Secondary	Immunogenicity for Measles (increasing measles antibody titer = 4 times)	- Percentage of infants with increasing measles antibody titer = 4 times	28 days
Secondary	Immunogenicity for Measles (seroconversion from seronegative to seropositive)	- Percentage of infants with transition of seronegative to seropositive.	28 days
Secondary	Immunogenicity for Rubella (Subjects with anti rubella titer =11 IU/ml)	- Percentage of subjects with anti rubella titer =11 IU/ml, 28 days after one dose of MR vaccine in Infants & Children.	28 days
Secondary	Immunogenicity for Rubella (Geometric Mean Titer)	- Geometric Mean Titer of Rubella antibody.	28 days
Secondary	Immunogenicity for Rubella (increasing rubella antibody titer = 4 times)	- Percentage of infants with increasing rubella antibody titer = 4 times	28 days
Secondary	Immunogenicity for Rubella (seroconversion from seronegative to seropositive)	- Percentage of infants with transition of seronegative to seropositive.	28 days